Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial

Background Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduc...

Full description

Saved in:
Bibliographic Details
Main Authors: Qi Wang, Yuqi Jia, Xuecheng Zhang, Yujiang Dong, Zhihui Hou, Wenqi Deng, Menghe Zhang, Qiurun Mu, Hongling Jia
Format: Article
Language:English
Published: BMJ Publishing Group 2022-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/12/e068318.full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850148678134661120
author Qi Wang
Yuqi Jia
Xuecheng Zhang
Yujiang Dong
Zhihui Hou
Wenqi Deng
Menghe Zhang
Qiurun Mu
Hongling Jia
author_facet Qi Wang
Yuqi Jia
Xuecheng Zhang
Yujiang Dong
Zhihui Hou
Wenqi Deng
Menghe Zhang
Qiurun Mu
Hongling Jia
author_sort Qi Wang
collection DOAJ
description Background Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation.Methods This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial.Discussion This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV.Ethics and dissemination The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible.Trial registration number ChiCTR 2100042646; Chinese Clinical Trial Registry.
format Article
id doaj-art-9071612a91604b84b037fdff184fcf2d
institution OA Journals
issn 2044-6055
language English
publishDate 2022-12-01
publisher BMJ Publishing Group
record_format Article
series BMJ Open
spelling doaj-art-9071612a91604b84b037fdff184fcf2d2025-08-20T02:27:11ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-068318Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trialQi Wang0Yuqi Jia1Xuecheng Zhang2Yujiang Dong3Zhihui Hou4Wenqi Deng5Menghe Zhang6Qiurun Mu7Hongling Jia83 Artificial Cell Engineering Technology Research Center, Tianjin, ChinaCollege of Acupuncture and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, ChinaKey Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Cardiology, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaDepartment of Radiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, National Clinical Research Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College/ National Center for Cardiovascular Diseases, Beijing, ChinaDepartment of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Cardiology, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaCollege of Acupuncture and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, ChinaDepartment of Acupuncture and Moxibustion, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaBackground Patients often experience postoperative nausea and vomiting (PONV) after catheter ablation of atrial fibrillation (AF) because of the use of opioids for anaesthesia and analgesia during the procedure. Some clinical trials have demonstrated that acupuncture-assisted anaesthesia (AAA) reduces opioid consumption and prevents PONV. Although several studies have been conducted on AAA, its safety and efficacy in AF catheter ablation remain unclear due to small sample sizes and a paucity of methodologically rigorous designs. Therefore, this trial was designed to evaluate the safety and efficacy of AAA in reducing PONV and morphine hydrochloride consumption during catheter ablation.Methods This single-centre, patient-blinded, randomised, non-penetrating sham-controlled trial will be conducted in China. A total of 100 patients will be randomly assigned to the AAA and conventional anaesthesia (CA) groups in a ratio of 1:1. The patients will receive AAA or CA plus sham acupuncture during catheter ablation and will be followed up for 30 days. The primary outcomes include the total amount of morphine hydrochloride consumed during catheter ablation and PONV within the first 24 hours after the procedure. The secondary outcomes include pain, nausea and vomiting, anxiety, patient’s ability to cope during catheter ablation, AF recurrence and quality of life, as assessed using the numeric rating scale. Adverse events will be recorded and their influence will be analysed at the end of the trial.Discussion This study will help in evaluating the safety and efficacy of AAA applied for AF catheter ablation in reducing opioid doses during the procedure and the occurrence of PONV.Ethics and dissemination The study has been approved by the Medical Ethics Committee of Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The results of the study will be published in peer-reviewed journals and presented at conferences if possible.Trial registration number ChiCTR 2100042646; Chinese Clinical Trial Registry.https://bmjopen.bmj.com/content/12/12/e068318.full
spellingShingle Qi Wang
Yuqi Jia
Xuecheng Zhang
Yujiang Dong
Zhihui Hou
Wenqi Deng
Menghe Zhang
Qiurun Mu
Hongling Jia
Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
BMJ Open
title Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_full Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_fullStr Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_full_unstemmed Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_short Acupuncture-assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting (PONV): study protocol for a randomised controlled trial
title_sort acupuncture assisted anaesthesia for catheter ablation of atrial fibrillation to reduce the consumption of morphine hydrochloride and postoperative nausea and vomiting ponv study protocol for a randomised controlled trial
url https://bmjopen.bmj.com/content/12/12/e068318.full
work_keys_str_mv AT qiwang acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT yuqijia acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT xuechengzhang acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT yujiangdong acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT zhihuihou acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT wenqideng acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT menghezhang acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT qiurunmu acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial
AT honglingjia acupunctureassistedanaesthesiaforcatheterablationofatrialfibrillationtoreducetheconsumptionofmorphinehydrochlorideandpostoperativenauseaandvomitingponvstudyprotocolforarandomisedcontrolledtrial